JP6622854B2 - Multimodal imaging system - Google Patents

Multimodal imaging system Download PDF

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JP6622854B2
JP6622854B2 JP2018108342A JP2018108342A JP6622854B2 JP 6622854 B2 JP6622854 B2 JP 6622854B2 JP 2018108342 A JP2018108342 A JP 2018108342A JP 2018108342 A JP2018108342 A JP 2018108342A JP 6622854 B2 JP6622854 B2 JP 6622854B2
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data collection
image data
probe
embodiment
optical
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JP2018149376A (en
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ハッチンズ,クリストファー
アトラス,マイケル
バーンズ,テレンス
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ライトラボ・イメージング・インコーポレーテッド
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4416Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to combined acquisition of different diagnostic modalities, e.g. combination of ultrasound and X-ray acquisitions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/0033Features or image-related aspects of imaging apparatus classified in A61B5/00, e.g. for MRI, optical tomography or impedance tomography apparatus; arrangements of imaging apparatus in a room
    • A61B5/0035Features or image-related aspects of imaging apparatus classified in A61B5/00, e.g. for MRI, optical tomography or impedance tomography apparatus; arrangements of imaging apparatus in a room adapted for acquisition of images from more than one imaging mode, e.g. combining MRI and optical tomography
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/0059Detecting, measuring or recording for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0062Arrangements for scanning
    • A61B5/0066Optical coherence imaging
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/0059Detecting, measuring or recording for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0082Detecting, measuring or recording for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes
    • A61B5/0084Detecting, measuring or recording for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes for introduction into the body, e.g. by catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852Catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0204Acoustic sensors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0233Special features of optical sensors or probes classified in A61B5/00

Description

This application is related to US Provisional Patent Application No. 61 / 727,997, filed November 19, 2012, and US Provisional Patent Application 61 / 728,006, filed November 19, 2012. And the patent application entitled “Interface Devices, Systems and Methods for Multimodal Probes” filed on Feb. 4, 2013, with agent docket number LLI-040. The entire disclosure of each document is incorporated herein by reference.

  The present invention relates to the field of imaging and, more particularly, to a data acquisition probe suitable for use in other imaging techniques such as optical coherence tomography and ultrasound and its probe components.

  Coronary artery disease is one of the leading causes of death worldwide. The ability to more appropriately diagnose, monitor, and treat coronary artery disease is important for extending lifespan. Optical coherence tomography (OCT) is a catheter-based imaging modality that uses light to penetrate a sample, such as a blood vessel wall, to produce an image of the sample. These images are useful for studying the structure of the vessel wall and the geometry of the vessel. Intravascular ultrasound (IVUS) is another imaging technique used to image blood vessels. Images generated using OCT are high resolution and more clearly show characteristics of other objects and objects of interest as well as structures such as plaques and stent struts when imaging blood vessels.

  In contrast, IVUS has a better penetration depth than OCT. IVUS is typically capable of penetrating tissues such as vessel walls within a range of about 4 millimeters (mm) to about 8 mm. Unfortunately, IVUS images are typically low resolution, making them more difficult to decipher. OCT has a shorter penetration depth and is typically capable of penetrating tissues such as vessel walls within a range of about 2 mm to about 3 mm. When considering the respective advantages of OCT and IVUS in terms of imaging depth and in other respects, these can be combined so that the respective advantages of OCT and IVUS do not include their associated drawbacks. There is a need to develop a system that integrates two imaging modalities.

  The present invention addresses these and other needs.

  In one aspect, the invention relates to an image data collection system, such as a probe, that includes an optical data collection subsystem and an ultrasound data collection subsystem. The optical data collection subsystem is configured to collect data for optical coherence tomography. While the ultrasound data collection subsystem or part thereof produces incident acoustic waves, the optical data collection subsystem or part thereof directs incident light waves. Each of these two subsystems then receives a return acoustic wave and a return light wave from the sample, respectively. Each received wave is compared against an incident wave or other data, and the sample can be evaluated, for example, by generating an ultrasound image or OCT image of the sample. Specifically, the received waves can each be analyzed as signals associated with two imaging modalities, where one is based on light and the other is based on acoustic waves. In one embodiment, both the optical data acquisition subsystem and the ultrasound image data acquisition subsystem are substantially perpendicular to the longitudinal axis of the probe or other axes offset from this axis, or these These light waves and acoustic waves are radiated at a predetermined angle with respect to the axis. Typically, the probe is rotatable within the blood vessel and translatable along the blood vessel. In one embodiment, the probe can be a component of an image data collection system.

  In one embodiment, the ultrasound subsystem is positioned at a distal position relative to the optical subsystem, and both subsystems are offset from each other by a predetermined distance. Both subsystems generate acoustic and light wave beams, respectively, so as to be substantially parallel or at a predetermined angle with respect to each other. In one embodiment, by offsetting the two beams, each beam collects data for the same region of the tissue sample at different points in time. Also, for embodiments in which the ultrasound subsystem rotates with the OCT subsystem, the delay while each subsystem is collecting data about the sample is the pullback rate relative to the offset distance between the respective data collection subsystems. It can be measured from the viewpoint. In one embodiment, the data collection subsystems are coaxially disposed with respect to each other and include a beam guide and an acoustic transducer, respectively.

  In one embodiment, the relative positions of the OCT beam and the ultrasound beam and their relative rotational speeds are configured to maintain the image quality of either the acquired IVUS image, the OCT image, or both images. The probe can also be configured to reconstruct a composite image along the same scanning line (scan line) using IVUS and OCT image data.

  In one embodiment, the ultrasound data collection subsystem is an ultrasound transducer and the optical data collection subsystem is a beam guide. Next, each of the light beam guide and the ultrasonic transducer can be a component of the probe tip. In one embodiment, the probe tip is placed in a sheath suitable for introduction into a blood vessel through which imaging can be performed. The sheath includes a transparent window configured to align with the beam guide and the ultrasonic transducer, thereby allowing the vessel wall to be imaged. In one embodiment, the sheath or a portion of the sheath can be optically and acoustically transparent so that light and acoustic waves can pass through the sheath, and image data is obtained for the sample. . In one embodiment, the sheath includes an optically and acoustically transparent window.

  In one embodiment, optically and acoustically transparent means that sufficient light and acoustic waves can pass through the window to generate OCT images and ultrasound images. The sheath can cause acoustic beam reflection, light beam reflection, or both. In one embodiment, the light beam guide and the acoustic beam generator are such that the light beam and the acoustic beam are angled with respect to each other so that direct reflection from such a sheath is prevented or reduced. Is positioned. Thus, in part, the present invention angles and / or positions light beam guides and acoustic beam generators to increase the signal-to-noise ratio in the resulting OCT, IVUS, or composite image thereof. About that. In part, this can be achieved by reducing the noise contribution of the light or acoustic beam scattered by the sheath in collecting the optical and acoustic signals for a given sample.

  In one aspect, the invention relates to an image data collection system. The system includes a data collection probe. The data collection probe includes a sheath and a probe tip. The probe tip includes an optical data collection subsystem, an acoustic data collection subsystem positioned distal to the optical data collection subsystem, and a probe body. The probe tip and probe body are disposed within the sheath, and the probe body includes an optical fiber in optical communication with the optical data collection subsystem.

  In one aspect, the invention relates to a dual-modality image data collection system. Dual mode is to perform ultrasound and optical coherence tomography in one embodiment. The system can include a data acquisition probe, a patient interface unit (PIU), and an image processor. In one embodiment, the PIU includes a PIU connector port. In one embodiment, the image processor includes an OCT system and an IVUS system, each system configured to receive data collected using a probe such as the probe tip described herein. The In one embodiment, the image processor includes one or more data acquisition systems (DAS) such as a data acquisition card, a processor, and an interferometer. In one embodiment, the probe includes a sheath and a probe tip. The probe tip includes a light beam guide and an acoustic beam generator. In one embodiment, the beam guide is configured to direct a light beam having a central axis, also referred to as the optical central axis. In one embodiment, the ultrasonic transducer is configured to direct an acoustic beam or acoustic wave having a central axis, also referred to as an acoustic central axis. An optical fiber is disposed in the probe and performs optical communication with the light beam guide. The optical fiber can define a longitudinal axis such that the light beam guide and the acoustic beam generator are disposed. In one embodiment, the light beam guide and the acoustic beam director generate a light beam and an acoustic beam such that they have a distance between the two beams in the range between about 300 microns (μm) to 400 μm. To be positioned.

  In one embodiment, the light beam director and the acoustic beam director are positioned to generate a light beam and an acoustic beam such that they have a distance between the two beams in the range between about 250 μm and 500 μm. Is done. In one embodiment, the distance between the two beams is measured from the centerline or center axis of each beam. In one embodiment, the light beam has a width in the range of about 20 μm to about 60 μm. In one embodiment, the acoustic beam has a width in the range of about 200 μm to about 300 μm.

  In one embodiment, the probe is configured to rotate by a PIU motor at a speed of about 100 hertz (Hz) to about 200 Hz. The PIU, in one embodiment, is configured to pull the probe at a speed between about 18 millimeters (mm) / second (s) to about 36 mm / s. In one embodiment, the rotatable connector or coupler and / or probe is rotationally balanced to reduce noise and vibration while collecting data at the rotational and pullback speeds described herein. ing. The connector port allows a disposable probe that includes a sheath and probe tip that are attached to the PIU and thereby rotate.

  In one embodiment, the image processor is configured to generate scan lines at a rate between about 25,000 lines / second and about 50,000 lines / second. In one embodiment, the image processor is configured to sample at a rate in the range of about 6 megahertz (MHz) to about 12 MHz. In one embodiment, the electrical conductor is selected from the group of high conductivity and high fatigue strength materials. In one embodiment, the helical pitch is between about 0.5 cm and about 1.5 cm.

  The data collection probe can include an optical fiber, a probe tip that is in optical communication with the optical fiber, and a first conductor and a second conductor. First and second conductors are spirally wound around the optical fiber. The wound optical fiber is then placed in a torque cable, also called a torque wire. In one embodiment, the conductor wrapped around the optical fiber is oxygen free copper. In one embodiment, an outer jacket is placed around the optical fiber. Next, in one embodiment, the conductor is wrapped around the outer jacket. In one embodiment, the diameter of the optical fiber including the outer jacket ranges between about 100 to about 175 μm. The probe, in one embodiment, is configured to be rotationally balanced.

  In one aspect, the invention relates to a method for collecting intravascular image data. This method, in some embodiments, rotates a rotatable coupler, also referred to herein as a connector, so that blood vessel motion is reduced during acquisition of optical coherence and ultrasound image data. Controlling the speed; transmitting optical coherence image data through a coupler rotatable along the optical fiber; and super-through a coupler rotatable along one or more conductors or conductive paths. Transmitting acoustic image data. In one embodiment, the rotational speed is between about 100 Hz and about 200 Hz. The method can further include controlling the pullback rate through the blood vessel so that blood vessel motion is reduced during the acquisition of optical coherence image data and ultrasound image data. The pullback speed can be between about 18 mm / s and about 36 mm / s.

  In one aspect, the invention relates to an image data collection system. The system includes a data collection probe. The data collection probe includes a sheath, a probe tip that includes a backing material defining a channel, an optical data collection subsystem in which a portion of the optical data collection subsystem is disposed within the channel, and a region of the backing material. An acoustic data collection subsystem positioned above and positioned distal to the optical data collection subsystem and a probe body. A probe tip and a probe body are disposed within the sheath, the probe body including an optical fiber in optical communication with the optical data collection subsystem.

  In one embodiment, the image data collection system further includes a torque wire defining a bore, wherein the plurality of conductors are wrapped around the optical fiber in a predetermined pattern, the conductors being acoustic data collection. A conductor in electrical communication with the subsystem and wrapped around the optical fiber is disposed in the bore. In one embodiment, the optical data collection subsystem includes a beam guide and the acoustic data collection subsystem includes an ultrasonic transducer. In one embodiment, the pattern is a helical pattern having a helical pitch in the range between about 0.5 cm to about 1.5 cm. In one embodiment, the image data collection system further includes a patient interface unit (PIU) and an image data collection system in electrical communication with the PIU. The PIU is configured to electrically couple the data collection probe to the image data collection system.

  In one embodiment, the image data collection system acquires data from the acoustic data collection subsystem and the optical data collection subsystem at an acquisition rate in the range of about 6 MHz to about 12 MHz. In one embodiment, the PIU includes a motor configured to retract the probe tip with a pullback speed in the range of about 18 mm / s to about 50 mm / s. In one embodiment, the probe tip includes a first section and a second section, the second section flaring outwardly with respect to the first section at a boundary between the respective sections, and one of the channels. The part straddles (spans) the first section. In one embodiment, the probe tip has an end face that includes a curved boundary. In one embodiment, the beam director and the ultrasonic transducer are separated by a predetermined distance.

  In one embodiment, the PIU includes a motor configured to rotate the data collection probe at a rotational speed in the range of about 100 Hz to about 200 Hz. In one embodiment, the beam director is angled to direct the beam at an angle in the range of about 0 ° to about 20 ° perpendicular to the longitudinal axis of the optical fiber. In one embodiment, the optical and acoustic subsystems are positioned so that the beams generated by the respective subsystems are substantially parallel. In one embodiment, the probe tip further includes a first elongate conductor and a second elongate conductor, and the beam light guide includes the first elongate conductor and the second elongate conductor. Each of the elongated conductors is in electrical communication with the ultrasonic transducer.

  In one embodiment, the probe tip further includes a backing material, the transducer is disposed on the backing material, and the acoustic wave disposed at an angle in the range of about 5 ° to about 15 °. It has a guide surface. In one embodiment, the acoustic subsystem and the optical subsystem are positioned coaxially with respect to each other. In one embodiment, the resistance of the plurality of conductors ranges from about 5 ohms (Ω) to about 20 Ω.

  In one aspect, the invention relates to an image data collection system. The system includes a data collection probe. The data collection probe includes: a sheath; a probe tip that includes a backing material; an optical data collection subsystem that includes a beam guide configured to direct a light beam that includes an optical center axis; and An acoustic data collection subsystem positioned above the region and positioned distal to the optical data collection subsystem, the acoustic data collection subsystem generating an acoustic wave comprising an acoustic center axis An acoustic data collection subsystem including an ultrasonic transducer configured to: a probe body, wherein the probe tip and the probe body are disposed within the sheath, the probe body comprising an optical data collection subsystem; A probe body including an optical fiber for optical communication. The beam director and the ultrasonic transducer are at a rotational speed of the probe in the range of about 100 Hz to about 200 Hz, and the optical center axis during the pullback speed of the data acquisition probe in the range of about 18 mm / s to about 36 mm / s. And the period when the light beams of the acoustic central axis intersect at a common reference point is positioned to be in the range of about M to about N.

  In one embodiment, M is 0.01 seconds and N is 0.02 seconds. In one embodiment, M is a value of about 1.2% of the cardiac cycle and N is a value of about 2.4% of the cardiac cycle. In one embodiment, the backing material defines a channel and a portion of the optical data collection system is disposed within the channel. In one embodiment, the image data collection system further includes a torque wire defining a bore, wherein the plurality of conductors are wrapped around the optical fiber in a predetermined pattern, the conductors being acoustic data collection. A conductor in electrical communication with the subsystem and wrapped around the optical fiber is disposed in the bore. In one embodiment, the pattern is a helical pattern having a helical pitch in the range between about 0.5 cm to about 1.5 cm.

  In one embodiment, the image data acquisition system further includes a patient interface unit (PIU) and an image data acquisition system in electrical communication with the PIU, wherein the PIU electrically connects the data acquisition probe to the image data acquisition system. Configured to be combined. In one embodiment, the image data collection system acquires data from the acoustic data collection subsystem and the optical data collection subsystem at an acquisition rate in the range of about 6 MHz to about 12 MHz. In one embodiment, the PIU includes a motor configured to retract the probe tip with a pullback speed in the range of about 18 mm / s to about 50 mm / s. In one embodiment, the probe tip includes a first section and a second section, the second section flaring outwardly with respect to the first section at a boundary between the respective sections, and one of the channels. The part straddles the first section. In one embodiment, the probe tip has an end face that includes a curved boundary. In one embodiment, the beam director and the ultrasonic transducer are separated by a predetermined distance.

  In one embodiment, the PIU includes a motor configured to rotate the data collection probe at a rotational speed in the range of about 100 Hz to about 200 Hz. In one embodiment, the beam director is angled to direct the beam at an angle in the range of about 0 ° to about 20 ° perpendicular to the longitudinal axis of the optical fiber. In one embodiment, the optical and acoustic subsystems are positioned such that the beams generated by the respective subsystems are substantially parallel.

  In one embodiment, the probe tip further includes a first elongate conductor and a second elongate conductor, wherein the beam light guide includes the first elongate conductor and Positioned between the second elongated conductors, each elongated conductor is in electrical communication with the ultrasonic transducer. In one embodiment, the transducer is disposed on the backing material and has an acoustic wave guiding surface disposed at an angle in the range of about 5 ° to about 15 °. In one embodiment, the acoustic subsystem and the optical subsystem are positioned coaxially with respect to each other. In one embodiment, the resistance of the plurality of conductors ranges from about 5Ω to about 20Ω.

  In one aspect, the invention relates to an image data collection system. The system includes a data collection probe. The probe includes a sheath; a probe tip that includes a backing material that defines a channel; an optical data collection subsystem, a portion of the optical data collection system being disposed within the channel. An acoustic data collection subsystem disposed above the backing material region and positioned distal to the optical data collection subsystem; a probe body, a probe tip and a probe body Is disposed within the sheath, the probe body having a probe body including an optical fiber in optical communication with the optical data collection subsystem.

  In one embodiment, the optical data collection subsystem includes a beam guide and the acoustic data collection subsystem includes an ultrasonic transducer. In one embodiment, the transducer is disposed on the backing material and has an acoustic wave guiding surface disposed at an angle in the range of about 5 ° to about 15 °. In one embodiment, the image data collection system further includes a torque wire defining a bore, wherein the plurality of conductors are wrapped around the optical fiber in a predetermined pattern, the conductors being acoustic data collection. A conductor in electrical communication with the subsystem and wrapped around the optical fiber is disposed in the bore. In one embodiment, the pattern is a helical pattern having a helical pitch in the range between about 0.5 cm to about 1.5 cm. In one embodiment, the beam director is angled to direct the beam at an angle in the range of about 0 ° to about 20 ° perpendicular to the longitudinal axis of the optical fiber.

  In one aspect, the invention relates to a method for collecting image data in a blood vessel having a wall. The method includes rotating a probe tip including a light beam guide and an ultrasonic transducer at a predetermined rotational speed; and transmitting incident light waves and acoustic waves using the light beam guide and the ultrasonic transducer, respectively. Receiving the reflected light wave and the reflected acoustic wave reflected from the wall using a light beam guide and an ultrasonic transducer, respectively; retracting the probe tip through the blood vessel at a predetermined pullback speed and from the wall In response to receiving reflected light waves and acoustic waves, obtaining an OCT data set and ultrasound data; and moving the blood vessel during acquisition of reflected light waves and reflected acoustic waves reflected from the wall surface The step of controlling the rotational speed.

  In one embodiment, the method further includes generating one or more images of the section of the wall using the OCT dataset, the ultrasound dataset, or both the OCT dataset and the ultrasound dataset. . In one embodiment, the method further includes controlling the pullback speed such that the pullback speed is in the range of about 18 mm / s to about 50 mm / s. In one embodiment, the rotational speed is controlled to be in the range of about 100 Hz to about 200 Hz. In one embodiment, the OCT data set and the ultrasound data set are acquired at a sample acquisition rate in the range of about 6 MHz to about 12 MHz. In one embodiment, the OCT data set and the ultrasound data set are acquired at a line acquisition rate ranging from 25 kilohertz (kHz) to about 50 kHz. In one embodiment, the method includes the steps of controlling the rotational speed and the pullback speed such that the period when the optical center axis and the acoustic center axis meet at a common reference point is in the range of about M to about N. In addition. In one embodiment, M is 0.01 seconds and N is 0.02 seconds. In one embodiment, M is a value of about 1.2% of the cardiac cycle and N is a value of 2.4% of the cardiac cycle.

1 is a schematic diagram of an image data collection system according to an exemplary embodiment of the present invention. FIG. 3 is a schematic diagram illustrating a perspective view of rotating ultrasound and light beams resulting from an image data collection probe according to an exemplary embodiment of the present invention. FIG. 3 is a schematic diagram illustrating a perspective view of rotating ultrasound and light beams resulting from an image data collection probe according to an exemplary embodiment of the present invention. FIG. 3 is a schematic diagram illustrating a perspective view of rotating ultrasound and light beams resulting from an image data collection probe according to an exemplary embodiment of the present invention. FIG. 3 is a schematic diagram illustrating a perspective view of a portion of an image data collection probe according to an exemplary embodiment of the present invention. FIG. 2 is a cross-sectional view of a portion of an image data collection probe according to an exemplary embodiment of the present invention and a schematic diagram illustrating optical and acoustic angular directions. 3 is an image of a portion of a probe body according to an exemplary embodiment of the present invention. 2 is a schematic diagram of a probe body and a probe tip according to an exemplary embodiment of the present invention. FIG. 2 is a diagram illustrating components of a multimodal data collection probe according to an exemplary embodiment of the present invention. 2 is a diagram illustrating components of a multimodal data collection probe according to an exemplary embodiment of the present invention. 2 is a diagram illustrating components of a multimodal data collection probe according to an exemplary embodiment of the present invention. 4 is an IVUS image showing penetration depth and resolution according to an exemplary embodiment of the present invention. 2 is an OCT image showing penetration depth and resolution according to an exemplary embodiment of the present invention.

  The drawings are not necessarily drawn to scale, and may instead be emphasized in describing the principles in general. The numbers are to be considered illustrative in all aspects and are not intended to limit the invention. The scope of the invention is defined only by the claims.

  In part, the present invention provides a multimodal data collection probe and related methods, systems, subsystems, and others that collect appropriate data for imaging a vessel or lumen of a region of interest. Concerning the components. This probe is multimodal because it can use more than one data collection mode. These modes can operate simultaneously or sequentially. These modes should be specified based on the type of wave used, such as acoustic or light waves, as well as any suitable imaging technique such as optical coherence tomography, ultrasound, or others. Can do. The probe can include a device or system configured to collect data for respective imaging modalities such as a beam guide and an acoustic wave generator.

  In one embodiment, the probe is configured for use in a body lumen such as an artery or other blood vessel. For example, the probe can be configured to collect optical coherence tomography (OCT) data and ultrasound (IVUS) data using light waves and acoustic waves, respectively. Data collected using one or more probe embodiments described herein is used to generate an image of a blood vessel, determine a fractional flow reserve, and Data relating to pressure in the cavity or other parameters or structures of interest can be collected.

  One or more probe embodiments may include a first receiver and a second receiver. Each of these receivers is configured to receive a signal such as an acoustic signal or an optical signal. The first and second receivers can be, for example, receivers, transceivers, transducers, detectors, devices or subsystems. In one embodiment, the first receiver is an intravascular ultrasound device or subsystem and the second receiver is an optical coherence tomography device or subsystem. These receivers are also configured to generate or direct signals such as acoustic waves and light waves. For example, the first receiver can include an ultrasound device that generates and receives acoustic waves. Similarly, by way of example, the second receiver can include optical elements that transmit light to and receive light from the sample. In one embodiment, the first receiver is in a distal position relative to the second receiver. In other embodiments, the first receiver can be adjacent to, touching, abutting, or otherwise positioned relative to the second receiver in various configurations.

  Each light beam, acoustic beam, or beam generating surface can be substantially parallel or inclined with respect to each other. In one embodiment, the optical receiver (receiver) is positioned adjacent to and in close proximity to the ultrasound receiver. A backing material is used to surround a portion of the light beam generating element and to form a surface suitable for supporting the ultrasonic element. A housing or cover can be used to partially surround the backing material. Additional details regarding exemplary system and probe embodiments are described herein.

  FIG. 1 illustrates a multimodal system 10 suitable for use with various probes and imaging modalities. The multimodal system 10 includes an image data acquisition system 12. The data acquisition system 12 is configured to collect multi-channel data, such as OCT data and ultrasound data, in one embodiment. The image data acquisition system can include a data acquisition device in electrical communication with the processor. The data acquisition system 12 can be configured to process multiple channels, such as channels including OCT image data and IVUS image data. The multimodal system 10 also includes one or more displays 15 suitable for displaying sample images generated using image data such as OCT, IVUS, or synthetic OCT / IVUS images of blood vessels. Can do. In one embodiment, the data acquisition system 12 converts the raw image data collected using the probe into an image that can be viewed by the user on the display 15 or other display. Display 15 can be used to display a graphical user interface to manipulate image data or control an image data acquisition session.

  One or more signal lines 17 and / or one or more control lines 17 communicate with the image data acquisition system 12 (whether wired or wireless) electrically, optically, or otherwise. . In one embodiment, a single line or bus is used to transmit control signals and image data. One or more components 18 can be in electrical or optical communication with the data acquisition system 12. In one embodiment, such one or more components 18 include an interferometer having a sample arm and a reference arm, an optical fiber, an optical receiver, one or more clock generators, an ultrasonic pulser, an ultrasonic wave A receiver and other components of the OCT and IVUS systems can be included.

  In one embodiment, multimodal system 10 includes a patient interface unit (PIU) 20. In one embodiment, the PIU 20 passes the two ultrasound-like imaging components or subsystems and OCT components of the probe 25 to the image data acquisition system 12 via one of the control lines or signal lines 17. Connecting. The control line and the signal line 17 are bidirectional so that data flows in one direction or both directions along a predetermined line. Typically, a control signal is sent from the system 12 to the PIU 20, and this control signal is sent from the PIU 20 to the probe tip 33 via the optical and conductive paths formed when the probe 25 is coupled to the connector 26. Is done. In one embodiment, the PIU 20 and probe 25 include a section of optical fiber that constitutes a section of the sample arm of the interferometer. The PIU includes electrical conductors such as wires that are used to transmit ultrasound data and control signals. The signal line 17 can include an optical path such as an optical fiber that is a part of the sample arm, and a conductor or a circuit element that transmits ultrasonic data and a control signal.

  The PIU 20 is connected to an image data collection probe 25 and includes a rotatable connector 26 configured to be removable from such probe 25. In one embodiment, the probe 25 is designed to be discarded after a predetermined data collection procedure. Thus, this connector 26 allows the probe to be used and imaged to image a blood vessel and allows a new probe to be optically and electrically coupled to the PIU 20. The probe 25 is configured to rotate in response to being driven by a motor. One or more motors are located in the PIU 20, and in one embodiment, such one or more motors are illustrated by the exemplary motor 22. While rotating within the blood vessel, the probe 25 collects image data for the surface of the blood vessel as the probe is pulled back through the blood vessel and is electrically connected across the PIU 20 and signal line 17 to connect to the system 12. And the data can be relayed along an optical path. In one embodiment, the PIU 20 includes one or more electrical couplers and / or one or more electrical couplers for connecting the electrical and optical components or subsystems of the probe to the electrical and optical components of the system 12. A plurality of optical couplers. One or more of such couplers can be disposed within the components of connector 26.

  In one embodiment, the smallest data unit of an OCT or IVUS image is referred to as a sample. The sample row along the light beam generated from the probe 25 with respect to the maximum imaging depth is called a scanning line. This light beam typically originates from a component of the probe tip 33, such as a light beam guide or an acoustic beam generator. The probe includes a probe body 28. The probe body 28 includes one or more sections of optical fiber that form an optical path and are arranged to rotate in response to operation of the motor. A beam director having a light receiving surface and a light transmitting surface is in optical communication with one or more optical fiber sections disposed on the probe body. One or more rotatable optical fibers that are part of the probe body 28 are disposed within the sheath 31. The sheath 31 is, in one embodiment, the outer body or portion of the catheter. The sheath may include a transparent window 34 that collects optical and acoustic image data.

  The beam guide is, in one embodiment, located within the sheath 31 and is part of the data collection subsystem 33. The data collection subsystem 33 is also referred to as a probe tip or cap 33. In one embodiment, the probe tip 33 includes a light beam director and an acoustic beam director. Further details regarding an exemplary probe tip 33 are shown in FIG. 3A, in which a probe tip 40 is shown as an embodiment of the general probe tip 33 of FIG. As shown, probe tip 40 includes an ultrasound and optical data collection subsystem.

  One or more electrical conductors in electrical communication with a probe tip acoustic beam generator, such as probe tip 33, can be wrapped around one or more lengths of optical fiber in probe body 28. . These conductors wound around the optical fiber in the probe body 28 can be placed on a torque wire, as described herein. Furthermore, the conductors thus wound can be in electrical communication with a rotary transformer or other conductive element disposed within the connector 26 or PIU 20 when the probe 25 is coupled to the PIU 20. In one embodiment, these various systems and components, such as those used to scan the sample and generate an image of the sample as the probe body, probe tip, and sheath rotate, include data Suitable for collecting.

  OCT and IVUS images typically acquire one scan line at a time. A cross-sectional image is then formed from the collected set of scan lines as the probe 25 rotates. Some exemplary image examples are shown in FIGS. 6A-6B. Further, to image a segment of an artery or other blood vessel, a probe, called a catheter, is moved longitudinally while rotating while being pulled or pulled back through the blood vessel. The probe can rotate in either clockwise A or counterclockwise B direction. The probe is pulled back in direction C away from the patient being imaged as the probe rotates in direction A or direction B. In this way, the probe acquires a set of cross-sectional images of a spiral pattern. The images arise from various scan lines associated with the vessel or artery slice of interest. The image is displayed as a cross-sectional image along one or more axes on the display 15. In one embodiment, the data acquisition system 12 converts the raw image data collected using the probe into an image that can be viewed by the user on the display 15 or other display.

  FIGS. 2A to 2C show schematic views of intravascular image acquisition of a dual-modality probe 35 configured so that the two imaging beams of the probe are displaced in the axial direction. As shown, in FIG. 2A, the probe tip 37 of the probe 35 has an ultrasonic component positioned distal to the optical component. Two parallel beams (labeled ultrasound and light) represent each pulse energy transmitted along each single scan line. Each spiral path in FIGS. 2A-2C, for an ultrasonic or acoustic beam, causes the rotation of the probe 35 to illuminate an area previously illuminated by an axially displaced light beam (specific rotation speed). And how much is needed (withdrawal speed).

Also shown in each of FIGS. 2A-2C are two rectangular blocks S OCT and S US . These blocks represent the sample size of IVUS and OCT images. The height of the sample box (sample size in the axial direction) is determined by how many samples are taken with the imaging line and its maximum penetration depth. The width of the box (sample size of rotation) is determined by how many scan lines were acquired in a single rotation and from the sensor how far a particular sample is from the center of rotation of the probe. The The depth of the box (lateral sample size) is determined by how fast the pullback is occurring with respect to the rotational speed of the probe tip 37. In one embodiment, the probe 35 is rotated so that fast dual mode acquisition is achieved, and the IVUS and OCT data is such that the vessel introduces imaging artifacts or unacceptable noise into the IVUS and OCT images. Collected without any exercise.

  Table 1 below summarizes the imaging parameters used in high speed dual mode acquisition with embodiments of the present invention and a conventional IVUS scan. 2A and 2C show the path traced by two embodiments of the present invention configured for high speed acquisition of ultrasound and OCT data. FIG. 2B illustrates a path traced at a conventional rotational speed and pullback speed for an ultrasound probe configured for IVUS imaging according to an embodiment of the present invention. From Table 1 and Table 2, based on the ratio of this fast acquisition value to the conventional IVUS value, the fast acquisition value represents a significant increase in applicable rate and speed compared to the conventional IVUS system. it is obvious.

  For a given dual mode data acquisition probe, the light beam and the acoustic beam are either coincident or separated by a predetermined distance. For image acquisition and alignment, it is best to match the beams, but to form a matching beam requires two overlapping beam receivers / beam generators, which is unavoidable for the performance of the data acquisition probe. Leading to deterioration. By displacing the two data collection subsystems axially away from each other (with the IVUS beam generator positioned at a distal position relative to the OCT beam guide), it can be constructed without sacrificing the sensor. Will be two beams spaced apart. In one embodiment, minimizing axial displacement is an important design feature of the dual mode data acquisition probe.

  As a result, coaxially positioning the IVUS transducer and OCT beam guide with an axial displacement between about 300 and about 500 μm affects the performance of one or both of the IVUS and optical data collection components. It can be made practically small without giving. Table 2 below highlights the differences and advantages associated with acquiring image data at conventional IVUS acquisition rates and high acquisition rates.

  In Table 2, the lateral sample size is obtained as the ratio of the retraction speed to the rotation speed. The scanning line acquisition speed is obtained as a scanning line per frame multiplied by the rotational speed. The sample acquisition speed is obtained as the number of samples per scan line multiplied by the scan line acquisition speed. The theoretical IVUS penetration depth is the theoretical depth such that ultrasound travels in water (at 1,540 m / s) and reflects back during a single sample acquisition period. Next, the rate of heart rate that occurs between OCT and IVUS scans is how long it takes for the ultrasound data collection element to move 0.360 mm at its pullback rate at a heart rate of 72 bpm. Based on crab.

  Table 2 also realigns images obtained using two axially displaced data collection elements such as beam guides and ultrasonic transceivers as part of a simultaneous recording process or other image data. Provide support for available considerations and promises. In one embodiment, the two imaging modalities can be substantially superimposed or recorded simultaneously because the pullback rate is controlled to essentially stop lumen (blood vessel) movement. For example, this can be achieved by using a pullback speed or rate in the range of about 18 to about 36 mm / s. In one embodiment, the pullback speed or rate ranges from 18 to about 50 mm / s. This allows the collection of image data to be performed when the lumen is not moving, and such cross-section “snapshots” are associated with the rotating probe and the associated acoustic and optical elements placed on the probe. Obtained by the data collection subsystem.

  By reducing the resolution along the lumen (blood vessel), the lateral sample size is stretched by pulling back at the rate described herein. Also, by pulling back at the rate described herein, the IVUS penetration depth is reduced by reducing the time required to wait for the return ultrasound echo. In contrast, imaging at pullback and rotational speeds near conventional IVUS values (as shown in Table 2) results in unacceptable motion blur between IVUS and OCT images. This motion blur is generated, in part, by luminal motion based on blood moving through the lumen, such as a heartbeat. Next, there are problems in imaging blood vessels using pullback and rotational speeds that exceed the fast acquisition value, such as greater than about 36 mm / s. In particular, such excessive pullback speed results in unacceptable IVUS imaging depth limitations. Imaging at pullback and rotational speeds near the pullback speed described herein results in reduced motion blur and increased IVUS penetration depth. As a result, an improved signal to noise ratio for the image is generated using the pullback rate according to the data collection probe embodiment.

  In order to achieve these imaging results using a probe with an axially displaced light beam guide and an acoustic beam generator, various operating parameters and attributes are first established, and then the above table. Controlled within certain predetermined thresholds, such as the values listed in 1 and Table 2 and elsewhere herein. Specifically, in one embodiment, the line transmission rate is selected or set to be between about 25 kHz and about 50 kHz. Next, in one embodiment, the sample acquisition rate is selected or set to be between about 6 MHz and about 12 MHz. The pullback speed while image data is collected is set to occur within a predetermined time at a pullback speed in the range of about 18 mm / s to about 36 mm / s. Similarly, during pullback, a probe having light and acoustic beam propagation elements rotates at a probe rotation speed in the range of about 100 Hz to about 200 Hz. The distance between the light beam and the acoustic beam is configured such that the distance between the two respective beams is in the range of about 300 to about 500 μm.

  In one embodiment, when collecting data for imaging a blood vessel at a high acquisition rate, the system processor is configured to generate ultrasound pulses at a rate in the range of about 25 kHz to about 50 kHz. Similarly, the data acquisition system is configured to acquire samples at a rate in the range of about 6 MHz to about 12 MHz.

Probe Tip Embodiment FIG. 3A shows an exemplary probe tip or cap 40 suitable for collecting image data for a sample such as an artery or other blood vessel. This probe tip can be rotated and pulled back as a component of the probe using the fast acquisition values and speeds described herein. The probe tip 40 is disposed within a sheath (not shown) and, in one embodiment, is attached to the probe body. For example, as shown in FIG. 1, the probe tip 33 is disposed in the sheath 31 and connected to the probe main body 28. In FIG. 3A, the optical fiber section 43 is part of the probe body.

  The probe tip 40 may include a first section 40a of the probe tip and a second section 40b of the probe tip. The joint between the first and second sections of the probe tip is such that the second section 40b has an outer surface that flares outward or is wider relative to the outer surface of the first section 40a. This means a transitional boundary where the width of the line changes. In one embodiment, the probe tip 40 is configured to use a first imaging mode such as ultrasound and a second imaging mode such as optical coherence tomography. Accordingly, the light beam and the acoustic beam propagate from the probe tip 40. Similarly, light and acoustic beams are scattered or reflected from a sample such as a blood vessel wall and then received by the light and acoustic subsystem. These received waves are transmitted as optical and electrical signals along the respective optical and conductive paths of the probe body through the PIU until they are received by the data acquisition system.

  Specifically, the light beam is probed after the component light of the beam is transmitted from the light source and transmitted along one or more optical fibers or other optical paths that are sections of the sample arm of the interferometer. Directed from the tip 40. For example, with reference to FIG. 1, the light source and interferometer can each be a component 18 of the system 10. Similarly, as shown in FIG. 3A, the optical fiber 43 is a section of the sample arm of the interferometer. The optical fiber 43 has a jacket applied to the optical fiber along several sections. In FIG. 3A, the jacket is not present on the optical fibers 43 near these sections, and the optical fibers 43 are fused to another fiber section, such as a beam expander 45.

  The section of probe body 28 shown includes an optical fiber 43. In one embodiment, a conductive element, such as one or more wires, is connected to a conductor 52, 54 that functions as two contacts or electrodes of an acoustic wave generator. The conductive elements continue from the conductors 52, 54 and are wrapped around the optical fiber 43 in a predetermined pattern as described herein and continue as part of the probe body 28. These wound conductive elements can be placed in a torque cable (not shown). As a result, the torque cable can be part of a probe body that includes an optical fiber 43 and a conductive element disposed on the torque cable. These conductive elements are shown for optical fiber sections and torque wires in FIGS. 4A and 4B.

  The optical fiber 43 is in optical communication with a beam guide 50 such as a lens, lens assembly or other beam directing system. The beam director 50 can include an angled end face of the optical fiber section. The optical fiber 43 terminates with a beam guide 50 in one embodiment. As shown, in the exemplary embodiment of FIG. 3A, optical fiber 43 is in optical communication with one or more optical fiber portions. These optical fiber portions or sections are not limited to GRIN lenses, but may include other portions of the optical train such as beam expander 45, GRIN lens 47, coreless optical fiber section 48, and the like. These optical elements are described in more detail herein.

  As shown in this embodiment, the optical fiber 43 is in optical communication with a first coreless beam expander 45 that expands the beam transmitted along the optical fiber 43 from the light source. The beam expander 45 is then in optical communication with an optical fiber section 47 of the GRIN lens that collimates the beam. Another coreless optical fiber section 48 is in optical communication with the GRIN lens 47. In one embodiment, the coreless optical fiber section 48 includes a beam guide 50 at its distal end or end face. In one embodiment, the beam guide 50 includes an angled reflective surface that is metallized and formed at the end of the fiber portion 48. The beam guide 50 can be configured to direct light at an angle C, as shown.

  As shown in the cross-sectional view of FIG. 3B, the beam guide 50 can be angled at an angle A relative to the longitudinal axis 29 of the optical fiber 43. Three vertical vectors or rays P1, P2, P3 are shown to provide the reference frame of FIG. 3B. P 1 is perpendicular to the axis 29. P2 is perpendicular to the axis 29 and / or the ray 53 passing through the backing 60 as shown. In one embodiment, the light propagates along a fiber core that is substantially aligned with the axis 29 from the light source. After the light is reflected from the beam guide 50, the light is then guided as light L through the sheath 31 to the sample. The acoustic wave AB is also guided to the sample 31. The angle A of the reflective surface 51 of the beam director 50 is about 40 ° with respect to the longitudinal axis 29, or in one embodiment, a light ray parallel to the longitudinal axis. In one embodiment, the angle C is approximately equal to (90 ° -2A °). In one embodiment, angle A ranges from about 30 degrees to about 50 degrees. In one embodiment, angle A ranges from about 35 ° to about 45 °. The acoustic beam AB and the light beam L can be separated by a distance BD measured with respect to the center of each of these two beams. In one embodiment, the BD ranges from about 250 μm to about 500 μm.

  In one embodiment, the angle of the reflective surface of the beam guide 50 is selected to be greater or less than 45 °. When the angle is about 40 °, the first ray propagating from the beam guide is a transparent window or other sheath (not shown) at an angle of 80 ° measured with respect to the longitudinal axis of the optical fiber. ). Since the incident angle at the sheath surface is less than about 90 °, return reflection from the sheath is reduced. Accordingly, in one embodiment, the angle of light rays striking the sheath from the beam guide is configured to be less than about 90 ° and greater than about 70 °. In one embodiment, the beam guide 50 is coaxial with the axis of rotation of the catheter. The light traveling along the optical fiber 43 is guided by the side projection lens structure (45, 47, 48, 50), so that the projected light beam is when the probe tip 40 is placed in the lumen. It hits the blood vessel wall.

  While OCT systems are optically based, ultrasound systems use electrical control signals to drive transducers and generate acoustic waves. These waves can be shaped to form a beam. Data collected using the transducer needs to be transmitted along the probe body 28 from the probe tip 40 for image formation. As described above, the two conductors or electrodes 52, 54 are disposed on either side of the beam guide 50 as shown. The first and second conductors 52 and 54 function as electrical signal lines for the ultrasonic detector or transducer 55. The transducer 55 is an example of an acoustic data collection subsystem or a component thereof. In one embodiment, the transducer 55 includes a stack layer that includes a piezoelectric material, such as lead zirconate titanate (PZT).

  In one embodiment, the transducer 55 has an uppermost acoustic matching layer 56 comprised of an ultrasonic generation stack (additional matching layers are possible). The first conductor 52 is in electrical communication with an ultrasonic transducer 55, such as a through layer 56, as shown. The acoustic beam is directed at a predetermined angle from the surface of layer 56 in one embodiment of the invention. The second conductor 54 is in electrical communication with the bottom or lower metallized surface of the piezoelectric material layer 58. Thus, in one embodiment, the conductors 52, 54 are in electrical communication with the acoustic wave generating transducer 55 via one or more layers of the transducer 55.

  The ultrasonic transducer 55 and the beam guide 50 can be oriented at an angle B and an angle C, respectively, as shown in FIG. 3B. In one embodiment, angle B and angle C are selected to be substantially equal. Angle B and angle C can range from 0 ° to about 20 °. Angle B and angle C are measured in a direction perpendicular to the longitudinal axis of the optical fiber portion, such as optical fiber 43. In one embodiment, angle B is about 10 °. In one embodiment, angle C is about 10 °. In one embodiment, the beams generated from the transducer 55 and the light guide 50 are parallel or substantially parallel. In one embodiment, the advantage of tilting both the acoustic beam and the light beam is that direct reflection from the sheath when the probe tip 40 is positioned (not shown), such as the sheath 31 of FIG. It is to avoid. In one embodiment, the ultrasonic transducer 55 includes a piezoelectric stack. In one embodiment, the length of the piezoelectric stack ranges from about 400 μm to about 800 μm. In one embodiment, the height of the piezoelectric stack ranges from about 40 μm to about 80 μm. In one embodiment, the thickness or width of the piezoelectric stack ranges from about 300 μm to about 600 μm.

  In one embodiment, the ultrasonic absorbing backing material 60 is disposed behind the transducer 55. This backing material 60 provides support for the beam guide 50 and the transducer 55. A cover or housing 62 may be attached to and / or partially surround the backing material 60. In one embodiment, the cover or housing 62 is optional. The backing material can include particles of high density material disposed within other materials such as epoxy. In one embodiment, tungsten particles can be placed in an epoxy resin as a backing material. Ceramic materials and other high density particles can be used as the backing material. In one embodiment, the cover or housing 62 includes a radiopaque material to enhance the visibility of the probe tip when an angiographic image is obtained from the patient during pullback. The cover or housing 62 can also include a higher strength metal to improve the structural integrity of the probe tip and the optical and acoustic data collection elements.

  In one embodiment, the backing material 60 can be molded to form a beam guide support. For example, in one embodiment, the backing material 60 defines channels or grooves for placing optical fibers, as shown. In one embodiment, the probe tip has an end surface 61 that has a curved cross-sectional portion or boundary, such as a cross-section that includes a circular, elliptical, or other curved portion. In one embodiment, the probe tip has a tapered shape such that its cross-sectional area varies along its length from the end face to the end of the fiber receiving section. In one embodiment, end surface 61 includes a curved lower boundary 61a as shown and a substantially linear boundary 61b.

  In one embodiment, the grooves or channels that span (over) section 40a are sized to receive optical fibers and / or other materials. Alternatively, the backing material 60 can define a planar support on which the beam guide 50 and transducer 50 are disposed. In one embodiment, the probe tip cross-section 40 varies along its length. For example, a portion of the cross section of the probe tip 40 that includes a groove or channel defined by the backing material has a first width that is less than the width of the probe tip when the backing material supports the transducer 55. . As shown in FIG. 3B, the backing material 60 includes a region that supports the beam guide 50 and one or more optical fiber-based elements in optical communication with the optical fiber 43, and a region that supports the transducer 56. Can be machined and / or molded to form. In one embodiment, the cross-section of the backing material that surrounds a portion of the beam guide 48 is the optical fiber 43 (when placed in a channel or groove), the beam expander 45, or a portion of the GRIN lens 47. Has a width dimension that is greater than the width of the cross-section of the backing material.

  As shown in FIG. 3A, the probe tip 40 has an ultrasonic transducer 55 at its distal end so that the light beam guide 50 is as close to the ultrasonic transducer 55 as possible. In this configuration, during data collection, the center of the light beam and ultrasound beam are separated by at least one half of the combined dimensions of the transducer and beam guide. For the exemplary transducer 55 as described above, in one embodiment, this application of the dimensions of the transducer and beam guide, with a beam guide (optical data collection subsystem) ranging from about 300 to about 400 μm. Identify the minimum separation distance from the ultrasonic transducer (acoustic data collection subsystem).

  The relative placement of the ultrasonic beam generator and the light beam light guide overcomes several problems associated with other design options. In particular, positioning the ultrasound data collection element before the optical data collection element, above this element, or also at a distal position of this element does not degrade any imaging modality to an unacceptable level. .

  In order to understand some of the other advantages of the placement of the ultrasound and OCT data collection elements of FIG. 3A, it is useful to consider such components or alternative placement options associated with this part. It is. For example, as one alternative embodiment to the arrangement of FIG. 3A, the light beam guide is placed in front of (in a distal position relative to) the ultrasonic beam generator. This embodiment requires an optical fiber that transmits OCT image data in order to pass the ultrasonic backing. This in turn sacrifices the ultrasonic backing material (both by introducing spurious reflections and reducing the amount of backing material to absorb the reflected energy). ), Shifting one of the light or acoustic data collection elements from the axis of rotation (either reducing the ultrasonic sensor area or increasing the OCT path length).

  As a second embodiment, aligning the light beam and the ultrasound beam not only shifts one or both data collection elements from the axis of rotation (reduces the size of the ultrasound transducer), It is necessary to sacrifice the performance of the ultrasound data collection subsystem (either by shadowing the ultrasound data or by requiring holes or tunnels through the ultrasound transducer for the optical fiber and light beam) . In the third embodiment, the light beam and the ultrasonic beam can be opposed to each other in the opposite direction. Such an option shifts both data acquisition elements from the axis of rotation (reduces the size of the ultrasound), sacrifices the ultrasound backing material, and the beam reconstruction is subject to non-uniform rotational distortion effects. ,There is a need.

  As described above with respect to FIG. 3A, the probe tip 40 is part of a data collection probe configured to collect optical and acoustic data for generating OCT and IVUS images. The probe tip is connected to the probe body 28 in one embodiment. The probe body includes an optical path and an electrical path through which signals are transmitted to and received from the probe chip. Further details regarding the probe body embodiment are shown in FIGS. 4A and 4B, as described above with respect to FIG.

  More particularly, FIGS. 4A and 4B show a section of probe body 65. As shown in FIG. 4A, the probe body includes a coated optical fiber 70 (preferably in the range of about 125 μm to about 155 μm in diameter). This fiber 70 is arranged centrally with respect to the other components of the probe body. A plurality of individual conductors 71 are wound around the optical fiber 70. These conductors 71 can be wires or other rigid or flexible conductors. These conductors 71 are wrapped symmetrically around the optical fiber so as to maintain rotational balance and rotational balance when the optical fiber rotates during data collection or at other times. In one embodiment, a radiopaque element 72 such as a marker can be used. The radiopaque marker 72 can be a metal sleeve or other device that appears in x-rays used for angiography.

  Torque wire 73 receives a section of fiber 70 and conductor 71. The marker 72 can be welded or otherwise joined to the torque wire 73, as shown by the joint 76 in FIG. 4B. In FIG. 4B, proximal and distal directions corresponding to those shown in FIGS. 1 and 3 are shown. On the right side of FIG. 4B, the optical fiber 70 is shown as a dotted line to indicate that the optical fiber is disposed within the torque wire 73. The conductor 71 is continuously wound around the fiber 70 in the torque wire. It is shown that the conductor 71 continues past the marker 72 of FIG. 4B. In one embodiment, the fiber 70 and the end of the conductor terminate in a terminal or probe connector. A probe tip 75 is shown attached to the probe body 65. The probe tip then includes an acoustic data collection subsystem 77 such as a transducer disposed as a component of the probe tip 75 relative to an optical data collection subsystem 79 such as a beam director. The optical element 79 is positioned at a proximal position of the acoustic element 77 as shown.

  The conductor 71 is a circuit component that constitutes a section of the conductive path between the acoustic data collection element 77 and the PIU that extends along the probe body until the conductive path reaches the data acquisition system. In one embodiment, considering the role of transmitting control signals and ultrasound data, the conductor 71 is selected to have a low actual resistance. Also, the electrical conductors are selected such that the impedance of the electrical conductors and any circuit elements or devices that make up the ultrasound signal transmission electronics match the impedance of the ultrasound signal reception electronics of the system 12. In one embodiment, the diameter of the wound fiber and the pitch of the spiral pattern are used to adjust the impedance of the transmitting device to match the impedance of the receiving device. For example, in one embodiment, the resistance value of conductor 71 is less than about 20 ohms (Ω) in one embodiment. In another embodiment, the resistance value is less than about 10Ω. In one embodiment, the conductor used has an impedance in the range of about 50 to about 100 ohms.

  In one embodiment, the assembly spirally wound around the conductor 71 on the optical fiber 70 is configured as a twisted pair transmission line. In one embodiment, the uniform spacing of the helical twists causes the position of the first conductor to be rotated symmetrically relative to the second conductor to remove (or cancel) noise induced from an external magnetic field. It becomes possible. Tightening the helical pitch removes more noise, and loosening the helical pitch allows for greater flexibility of the cable. For example, in one embodiment, the pitch is selected to be between about 0.5 mm and about 1.5 mm to balance noise reduction against cable flexibility.

  The wound assembly of optical fiber 70 and conductor 71 is configured to have fatigue resistance. In one embodiment, the plurality of conductors 71 can include two pairs of conductors. Two pairs of 44 gauge oxygen-free copper conductors (having high conductance and high fatigue strength) wound at a helical pitch of about 0.5 to about 1.0 cm have resistances in the ranges described herein and The impedance is satisfied. As a result of winding the conductor 71 around the optical fiber 70, the total diameter of the wound fiber increases to be in the range of about 0.009 "(inches) to about 0.011" (inches). This assembly consisting of the optical fiber 70 and the wound conductor 71 is partially placed inside the torque cable 73. The conductor 71 is in electrical communication with conductors disposed on the probe tip 65 and the acoustic element 79. In one embodiment, a radiopaque marker 76 is attached to the end of the torque cable 73. This marker improves the visibility of the probe tip 65 and provides a solid material for connecting the probe tip 65.

  The torque cable 73 is a series of helical wires wound in two opposite directions, and this cable has rotational rigidity (transmits torque) but is flexible when bent. Torque cable 73 is similar to the cable used with IVUS-only or OCT-only catheters. The difficulty of combined catheters is to fit both electrical and optical elements inside the torque cable 73 without compromising their performance characteristics. Increasing the outer diameter of the torque cable is undesirable because the sheath and guide catheter will also increase thereafter. As a result, the probe requires a larger probe than a typical 5 or 6 French guide catheter as used in catheter examination procedures.

  FIG. 5A shows a probe tip 90 that includes an ultrasonic transducer 92, also referred to as an acoustic wave or ultrasonic data acquisition subsystem, or components thereof. An optical fiber 91, which is part of the probe body, is shown positioned with respect to the components of the probe tip 90. A beam guide 93 configured to transmit and receive imaging light is also part of the probe tip 90. Also, as shown, the conductors 94, 95 are in electrical communication with the ultrasonic transducer 92 by being bonded to contact points on the probe tip 90. The conductors 94 and 95 are disposed on both sides of the beam guide 93. The conductor 94 is used to transmit signals and control the ultrasonic transducer 92. The conductors 94, 95 can serve as contacts for conductive elements such as wires configured to wrap around the fiber 91. As shown, ultrasonic transducer 92 is disposed on backing material 96 in one embodiment. The backing material 92 can have an arrowhead shape including a flare side surface and a neck portion narrowed near the optical fiber. The backing material, in one embodiment, can also be shaped to be part of a cone, such as a frustum or other conical curve.

  FIG. 5B shows the probe tip 90. The torque cable or wire 98 has an optical fiber disposed at least partially therein so as to be in optical communication with the beam guide 93. In one embodiment, the torque cable or wire 98 can include a radiopaque marker 99 positioned near the probe tip 90. The probe tip 90 is attached to this marker 99 in one embodiment. The marker 99 can then be attached to the torque wire 98.

  In FIG. 5C, a section of the data collection probe 100 is shown. The sheath 102 is shown with a probe tip 104 disposed therein. The probe tip 104 includes a beam guide and an ultrasonic transducer. The torque cable 105 is disposed inside the sheath 100. Radiopaque marker 108 is adjacent to and attached to probe tip 104 and torque cable 105.

  The probe tips and related functions described herein can be used for generating cross-sectional views of blood vessels such as arteries. An example of such a cross-sectional view can be seen in FIGS. 6A and 6B. FIG. 6A illustrates penetration depth, resolution generated using a processor-based system, and a data set collected using a data collection probe with an ultrasonic transducer, as described herein. It is an IVUS image. The IVUS image in FIG. 6A shows the penetration depth at which IVUS is feasible (compared to OCT). FIG. 6B shows the penetration depth, resolution generated using a processor-based system, and a data set collected using a data collection probe with a beam director, as described herein. It is the OCT image shown. The OCT image in FIG. 6B shows a high resolution (compared to IVUS) where OCT can be achieved.

  The specification discusses the present invention in the context of optical coherence tomography. However, these embodiments are not intended to be limiting and one of ordinary skill in the art will appreciate that the invention can be used with other diagnostic imaging modalities or general optical systems.

  The terms light and electromagnetic radiation are used interchangeably herein so that each term includes all wavelength (and frequency) ranges and individual wavelengths (and frequencies) within the electromagnetic spectrum. Similarly, the terms apparatus and equipment are also used interchangeably. In part, embodiments of the present invention include, but are not limited to, electromagnetic radiation and light sources of this component; systems, subsystems, and equipment including such light sources; Or mechanical, optical, electrical, and other suitable devices, such as those used to communicate with such systems; and methods relating to each of the aforementioned systems and the like. Thus, an electromagnetic radiation source can be any device, substance, system, or combination of devices that emit, re-radiate, transmit, emit or otherwise generate light of one or more wavelengths or frequencies. Can be included.

  An example of an electromagnetic radiation source is a laser. A laser is a device or system that generates or amplifies light by a process of stimulated emission of radiation. While enumerating the types and variations of laser designs and becoming too broad to continue the story, some non-limiting examples of lasers suitable for use in embodiments of the present invention include wavelength Tunable lasers (sometimes called swept source lasers), superluminescent diodes, laser diodes, semiconducting lasers, mode-locked lasers, gas lasers, fiber lasers, solid state lasers, waveguide lasers, laser amplifiers (sometimes optical amplifiers) A laser oscillator, an amplified spontaneous emission laser (sometimes referred to as a mirrorless laser or a super-radiation laser).

  The aspects, embodiments, features and examples of the invention are to be considered in all respects as illustrative and are not intended to limit the invention, the scope of the invention being defined by the claims. Only prescribed. Other embodiments, variations, and uses will become apparent to those skilled in the art without departing from the spirit and scope of the invention as set forth in the claims.

  The use of headings and items in this application does not limit the invention. Each item can be applied to any aspect, embodiment, or function of the invention.

  Throughout this application, a configuration of the present teachings is described when a configuration is described as having, including, or comprising a particular component, or when a process is described as including, having, or with a particular processing step Consisting essentially of enumerated components, or consisting of enumerated components, or the process of the present teachings consists essentially of enumerated processing steps, or consists of enumerated configurations It is contemplated.

  In this application, when an element or component is included in and / or selected from the list of listed elements or components, the element or component is considered to be any of the listed elements or components. It should be understood that and can be selected from a group consisting of two or more of the listed elements or components. Further, the elements and / or functions of any component, apparatus, or method described herein, whether explicitly or implicitly described herein, depart from the spirit and scope of the present teachings. It should be understood that they can be combined in various ways.

  The use of the terms “include, includes, including” and “have, has, having” is generally open-ended and non-limiting unless specifically stated otherwise. Should be understood as.

  The use of the singular herein includes the plural (and vice versa) unless specifically stated otherwise. Also, unless the context clearly dictates otherwise, the singular form “a, an, the” includes the plural. In addition, when the term “about” is used before a quantitative value, the present teachings also include the specific quantitative value itself, unless specifically stated otherwise.

  It should be understood that the order or sequence of steps for performing a particular operation is irrelevant so long as the present teachings are usable. Further, two or more steps or operations may be performed simultaneously.

  It should be understood that the drawings and description of the invention are simplified to show such elements as are relevant for a clear understanding of the invention, with the exclusion of other elements for clarity. is there. However, those skilled in the art will recognize that these and other elements are desirable. However, such elements are known in the art, and since these elements do not facilitate a better understanding of the present invention, a discussion of such elements is not provided herein. It should be understood that the drawings are presented for illustrative purposes and are not presented as structural diagrams. Details omitted and variations or alternative embodiments are within the knowledge of one of ordinary skill in the art.

  The examples presented herein are intended to illustrate possible and specific implementations of the invention. It should be understood that the examples are primarily intended for the purpose of describing the present invention to those skilled in the art. There may be changes to these figures or operations described herein without departing from the spirit of the invention.

Also, while specific embodiments of the invention have been described herein for purposes of illustrating the invention and not for purposes of limiting the invention, those skilled in the art will recognize elements, steps, structures, and It will be understood that many variations in part detail, material, and arrangement may be made within the principles and scope of the invention without departing from the invention as set forth in the claims.

Claims (20)

  1. An image data collection system, the image data collection system comprising:
    A data collection probe,
    The data collection probe is
    Sheath,
    A probe tip;
    A probe body, and
    The probe tip is
    A backing material defining the channel;
    An optical data collection subsystem, wherein a portion of the optical data collection subsystem is disposed in the channel;
    An acoustic data collection subsystem disposed over the backing material region and further distal to the distal end of the optical data collection subsystem;
    The probe tip and the probe body are disposed within the sheath, the probe body including an optical fiber in optical communication with the optical data collection subsystem;
    Image data collection system.
  2.   The image data collection system of claim 1, wherein the optical data collection subsystem includes a beam guide and the acoustic data collection subsystem includes an ultrasound transducer.
  3. An ultrasonic transducer is disposed on the backing, and the ultrasonic transducer is disposed at an angle ranging from about 5 ° to about 15 ° from a direction perpendicular to the longitudinal axis of the optical fiber. The image data collection system according to claim 1, comprising a surface.
  4.   A torque wire defining a bore, wherein a plurality of conductors are wound around the optical fiber in a predetermined pattern, the conductors being in electrical communication with the acoustic data collection subsystem; The image data collection system according to claim 3, wherein the conductor wound around is disposed in the bore.
  5.   The image data collection system of claim 4, wherein the pattern is a helical pattern having a helical pitch ranging from about 0.5 centimeters (cm) to about 1.5 cm.
  6. Beam light guide is determined angle to direct the beam at an angle in the range from vertical direction of about 0 ° ~ about 1 ° to the longitudinal axis of said optical fiber, the image data according to claim 3 Collection system.
  7.   Further comprising a patient interface unit (PIU) and an image data acquisition system in electrical communication with the PIU, wherein the PIU is configured to electrically couple the data acquisition probe to the image data acquisition system. Item 2. The image data collection system according to Item 1.
  8.   The image data acquisition system of claim 1, wherein the image data acquisition system acquires data from the acoustic data acquisition subsystem and the optical data acquisition subsystem at an acquisition rate in the range of about 6 megahertz (MHz) to about 12 MHz. system.
  9.   The image data collection system of claim 7, wherein the PIU comprises a motor configured to retract the probe tip at a pullback speed in the range of about 18 millimeters (mm) / second to about 50 mm / second.
  10.   The probe tip includes a first section and a second section, the second section flaring outwardly relative to the first section at a boundary between the sections, and a portion of the channel is: The image data collection system of claim 7, extending to the first section.
  11.   The image data collection system according to claim 1, wherein the probe tip has an end surface including a curved boundary.
  12.   The image data acquisition system according to claim 1, wherein the beam guide and the ultrasonic transducer are separated by a predetermined distance.
  13.   The image data acquisition system of claim 7, wherein the PIU comprises a motor configured to rotate the data acquisition probe at a rotational speed in a range of about 100 hertz (Hz) to about 200 Hz.
  14. Beam light guide is determined angle to direct the beam at an angle in the range from vertical direction of about 0 ° ~ about 20 ° to the longitudinal axis of said optical fiber, the image data according to claim 1 Collection system.
  15.   The image data collection system of claim 1, wherein the optical data collection subsystem and the acoustic data collection subsystem are positioned such that beams generated by the respective subsystems are substantially parallel.
  16.   The probe tip further includes a first elongate conductor and a second elongate conductor, and the beam guide is positioned between the first elongate conductor and the second elongate conductor; The image data collection system of claim 1 in electrical communication with a sonic transducer.
  17. An ultrasonic transducer is disposed on the backing, and the ultrasonic transducer is disposed at an angle ranging from about 5 ° to about 15 ° from a direction perpendicular to the longitudinal axis of the optical fiber. The image data collection system according to claim 1, comprising a surface.
  18.   The image data collection system of claim 1, wherein the acoustic data collection subsystem and the optical data collection subsystem are positioned coaxially with respect to each other.
  19. Beam light guide is an optical fiber longitudinal axis at an angle in the range of 5 ° to 20 ° from the vertical direction are determined angle to direct the light beam in the distal direction, of claim 1 Image data collection system.
  20. The PIU has a motor for rotating the data collection probe, and the rotation speed is such that the movement of the blood vessel is reduced during acquisition of reflected light and acoustic waves from the wall. The image data collection system according to claim 7.
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WO2014077870A1 (en) 2014-05-22
JP2016501079A (en) 2016-01-18
US20140142436A1 (en) 2014-05-22
JP6603298B2 (en) 2019-11-06
JP6352287B2 (en) 2018-07-04
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WO2014077871A3 (en) 2015-06-18
WO2014077870A8 (en) 2015-06-11
EP2919659A1 (en) 2015-09-23
JP2015534896A (en) 2015-12-07
JP6267718B2 (en) 2018-01-24
EP2919658A4 (en) 2016-07-20
WO2014077871A2 (en) 2014-05-22

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